International safety notice
Alert 2830 (Technovigilance) HP Bioproteses Ltda Sphera Duo Neonatal Hydrocephalus Derivation Incorrect labeling in specific batch units.
Brazil / Anvisa · BRA · Mar 22, 2019
Key facts
| Title | Alert 2830 (Technovigilance) HP Bioproteses Ltda Sphera Duo Neonatal Hydrocephalus Derivation Incorrect labeling in specific batch units. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Sphera Duo Neonatal Hydrocephalus Derivation Technical Name: Hydrocephalus Valve ANVISA registration number: 10166360060 Risk Class: IV Affected model: NNM9015D Affected serial numbers: LOT 079 series 01 to 22, 27 to 40 |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO HP BIOPROTESES LTDA CNPJ 54801196000142 RUA MARIA JOSÉ RANGEL 83 SÃO PAULO SP TEL 11 38537625 EMAIL MARCIAHPBIOCOMBR FABRICANTE DO PRODUTO HP BIOPROTESES LTDA RUA MARIA JOSÉ RANGEL 83 SÃO PAULO SP 04650180 BRASIL |
| Models | 10166360060, NNM9015D |
| Date | Mar 22, 2019 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1